Cardiovascular risk reduction study: supported by an integrated dietary approach

Not Applicable

Completed

• Conditions: Cardiovascular disease; Circulatory System

• Registration Number: ISRCTN92382106
• Lead Sponsor: King's College London (KCL) (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-11
• Last Update Posted: 20 February 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 196

Inclusion Criteria

Healthy men and women, aged 40 - 70 years

Exclusion Criteria

1. A reported history of angina, myocardial infarction, peripheral vascular disease, congenital heart disease or stroke
2. Asymptomatic atrial fibrillation
3. Type 1 or type 2 diabetes mellitus (fasting plasma glucose greater than 7 mmol/L)
4. Seated blood pressure greater than 160/105 mmHg
5. Current use of medication for lowering blood cholesterol (statins) or blood pressure
6. Body mass index less than 18.5 and greater than 35 kg/m2
7. An overall risk of cardiovascular disease over the next ten years of greater than 20% assessed according to current NICE guidelines in combination with untreated high blood pressure or raised cholesterol
8. Clinical history of cancer (excluding basal cell carcinoma) in the past five years
9. Chronic renal, liver or inflammatory bowel disease
10. Current cigarette smoker (confirmed by urinary cotinine analysis)
11. History of substance abuse or alcoholism (previous weekly alcohol intake greater than 60 units/men or 50 units/women)
12. Current self-reported weekly alcohol intake not exceeding 21 units for women and 28 for men
13. Currently pregnant, planning pregnancy or having had a baby in the last 12 months
14. Unwilling to follow the protocol and/or give informed consent
15. Unwilling to refrain from use of dietary supplements
16. Unwilling to restrict consumption of oily fish
17. Weight change of greater than 3 kg in preceding 2 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified